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Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

This study has been terminated.
(Change in Formulation)
Sponsor:
Information provided by:
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00205907
First received: September 13, 2005
Last updated: February 27, 2008
Last verified: February 2008
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.


Condition Intervention Phase
Pulmonary Emphysema
 Biological: BLVR Hydrogel
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/Phase 2 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema

Resource links provided by NLM:

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Product-related life-threatening adverse events, permanently disabling complications and deaths [ Time Frame: 1 year post treatment ] [ Designated as safety issue: Yes ]
  • FEV1 [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • MRC Dyspnea Score [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Six-Minute Walk Test [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Health-Related Quality of Life [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function tests [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Lung volume measures [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: January 2005
Study Completion Date: April 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single
BLVR treatment
 Biological: BLVR Hydrogel
10 mL BLVR Hydrogel

Detailed Description:

Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.

Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. The current study will evaluate the safety and efficacy of this procedure in patients with advanced emphysema.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include:

  • Clinical diagnosis of advanced heterogeneous emphysema
  • Age > 18 years at the time of initial presentation
  • Clinically significant dyspnea (MRC Dyspnea >/= 2)
  • Failure of standard medical therapy to provide relief of symptoms
  • BUN, creatinine, ALT, AST, alkaline phosphatase, WBC, hematocrit, platelet count, PT and PTT within normal limits
  • Pulmonary function tests

Exclusion Criteria:

  • Alpha-1 protease inhibitor deficiency verified by a serum level of < 80 mg% or knowledge of PI*ZZ genotype
  • Body mass index < 15 kg/m2 or > 35 kg/m2
  • Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
  • Tobacco use within 16 weeks of the initial clinic visit
  • Allergy to fish or pork products or sensitivity to tetracycline
  • FEV1 <20% with DLCO <20% or homogeneous disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205907

Locations
Israel
Chaim Sheba (Tel Hashomer) Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Aeris Therapeutics
Investigators
Principal Investigator: Issahar Ben-Dov, MD The Chaim Sheba Medical Center
  More Information

Additional Information:
Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. Epub 2002 Oct 11.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Edward P Ingenito, MD, PhD, Medical Director & CSO, Aeris Therapeutics Inc
ClinicalTrials.gov Identifier: NCT00205907     History of Changes
Other Study ID Numbers: C04-003
Study First Received: September 13, 2005
Last Updated: February 27, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Aeris Therapeutics:
BLVR
emphysema
COPD
 COLD
chronic obstructive pulmonary disease
pulmonary emphysema

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013